Y Chen

Hematology Oncology Consultants

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ОВ

Олександр Войтко

National University of Civil Defense of Ukraine

Artem Poltoratskiy

Institute of Oncology NN Petrov

Dmytro Trukhin

Odessa National Medical University

MÖ

Mustafa Özgüroğlu

Istanbul University-Cerrahpaşa

Libor Havel

Charles University

Niels Reinmuth

Asklepios Fachkliniken München-Gauting

Galina Statsenko

Budgetary Health Care Institution of the Omsk Region "Clinical Oncology Center"

Igor Bondarenko

Dnipropetrovsk State Medical Academy

G Losonczy

Semmelweis University

Luís Paz-Ares

Hospital Universitario 12 De Octubre

Cooperative Institutions

AstraZeneca (United States)

AstraZeneca (United Kingdom)

Tennessee Oncology

AstraZeneca (Japan)

LungenClinic Grosshansdorf

Institut Gustave Roussy

Hospital Universitario 12 De Octubre

Research Institute Hospital 12 de Octubre

Shanghai Chest Hospital

Sarah Cannon

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Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN

ESMO Open (2022)

Luís Paz-Ares Y Chen Niels Reinmuth Katsuyuki Hotta Dmytro Trukhin

In the phase III CASPIAN study, first-line durvalumab in combination with etoposide plus either cisplatin or carboplatin (EP) significantly improved overall survival (OS) versus EP alone in extensive-stage small-cell lung cancer (ES-SCLC). Durvalumab plus tremelimumab plus EP numerically improved OS versus EP, but did not reach statistical significance. Here we report updated OS in censored patients after median follow-up of >3 years.805 patients with treatment-naïve ES-SCLC were randomized 1 : 1 : 1 to durvalumab plus EP, durvalumab plus tremelimumab plus EP, or EP. The two primary endpoints were OS for durvalumab plus EP versus EP and for durvalumab plus tremelimumab plus EP versus EP.As of 22 March 2021 (median follow-up 39.4 months, 86% maturity), durvalumab plus EP continued to demonstrate improved OS versus EP: hazard ratio (HR) 0.71 [95% confidence interval (CI) 0.60-0.86; nominal P = 0.0003]; median OS was 12.9 versus 10.5 months, and 36-month OS rate was 17.6% versus 5.8%. Durvalumab plus tremelimumab plus EP continued to numerically improve OS versus EP: HR 0.81 (95% CI: 0.67-0.97; nominal P = 0.0200); median OS was 10.4 months, and 36-month OS rate was 15.3%. Twenty-seven and nineteen patients in the durvalumab plus EP and durvalumab plus tremelimumab plus EP arms, respectively, remained on durvalumab treatment at data cut-off.Three times more patients were estimated to be alive at 3 years when treated with durvalumab plus EP versus EP, with the majority still receiving durvalumab at data cut-off, further establishing durvalumab plus EP as first-line standard of care for ES-SCLC.

Durvalumab

Tremelimumab

10.1016/j.esmoop.2022.100408

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Citations (176)

Durvalumab+ Tremelimumab + Platin-Etoposide in first-line extensive-stage SCLC (ES-SCLC): 36-month Overall Survival from the Phase 3 CASPIAN study

Pneumologie (2022)

H Bischoff L. Paz-Ares Y Chen Niels Reinmuth K Hotta

Background In the Phase 3 CASPIAN study of etoposide + cisplatin/carboplatin (EP) ± durvalumab (D) ± tremelimumab (T) as first-line treatment of ES-SCLC, D + EP demonstrated a statistically significant improvement in OS vs EP alone (data cut-off [DCO]: 11 Mar 2019; HR 0.73 [95% CI 0.59–0.91; p=0.0047]). In a subsequent analysis after a median follow-up of 25.1 mo (DCO 27 Jan 2020), OS benefit with D + EP vs EP was sustained (HR 0.75 [95% CI 0.62–0.91; nominal p=0.0032]), and D + T + EP numerically improved OS vs EP (HR 0.82 [95% CI 0.68–1.00; p=0.0451]), but did not reach statistical significance (p≤0.0418). Here we report updated OS data after a median follow-up of >3 years.

Durvalumab

Carboplatin

Tremelimumab

10.1055/s-0042-1747800

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Citations (0)

CASPIAN: OS results from a randomised Phase III study of first-line Durvalumab ± Tremelimumab plus chemotherapy in ED-SCLC: OS-Ergebnisse von CASPIAN, einer randomisierten Phase-III-Studie zur Erstlinientherapie von Durvalumab ± Tremelimumab + Chemotherapie beim Extensive Stage kleinzelligen Lungenkarzinom (ES-SCLC)

Pneumologie (2020)

Niels Reinmuth Luís Paz-Ares Y Chen Katsuyuki Hotta Dmytro Trukhin

Hintergrund: Die Immuncheckpointblockade von PD-1/PD-L1 zeigte in Kombination mit einer platin-basierten Chemotherapie (CT) verbesserte klinische Ergebnisse für Patienten mit kleinzelligem Lungenkarzinom im Stadium Extensive Disease (ES-SCLC). Die Therapie mit Durvalumab (D), einem selektiven, hoch-affinen, humanen IgG1 monoklonalen Antikörper, der die Bindung von PD-L1 an PD-1 und CD80 blockiert sowie Tremelimumab (T), einem selektiven humanen IgG2 monoklonalen Antikörper gegen CTLA4, könnte additive oder synergistische Effekte bieten. Durvalumab zeigte in frühe Phase Studien eine andauernde klinische Aktivität mit einem handhabbaren Sicherheitsprofil als Monotherapie als auch in Kombination mit Tremelimumab bei vorbehandelten ES-SCLC Patienten (NCT01693562; NCT02261220; NCT02937818). CASPIAN (NCT03043872) ist eine randomisierte, multizentrische, offene, Sponsor-verblindete Phase 3 Studie mit Durvalumab ± Tremelimumab in Kombination mit Etoposid und platin-basierter Chemotherapie (EP) als Erstlinientherapie für ES-SCLC Patienten.

Durvalumab

Tremelimumab

10.1055/s-0039-3403350

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